FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CDRH Proposes User Fee Program Enhancements

[ Price : $8.95]

A recent medical device user fee negotiation meeting sees CDRH proposing numerous program enhancements to improve consistency and ...

FDA Should Reverse Dispute Resolution Stance: Attorneys

[ Price : $8.95]

Hyman, Phelps & McNamara asks FDA to reverse a recent guidance limiting the way drug sponsors can appeal FDA decisions they believ...

Medisca API Improperly Labeled: FDA

[ Price : $8.95]

FDAs New York District Office warns Medisca about mislabeled APIs intended for use by compounding pharmacies and other violations....

Public Citizen Hits Orphan Drug Incentive Proposal

[ Price : $8.95]

Public Citizen blasts a 21st Century Cures provision to reward companies with longer patent periods and higher prices for branded ...

Progress in PDUFA 6 Talks

[ Price : $8.95]

FDA releases minutes describing progress made during discussions with industry at three PDUFA 6 steering committee meetings and on...

Dignitana Cooling Cap Cleared for Reducing Chemo Hair Loss

[ Price : $8.95]

FDA clears a Dignitana de novo petition to allow marketing of the DigniCap Cooling System, a cooling cap designed to reduce hair l...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Applied Nutriceuticals, DBM Nutrition, ICF International, Medisca Pharmaceutique...

Pfizer Awards $4 Million for Breast Cancer Research

[ Price : $8.95]

Pfizer says it has awarded five grants totaling more than $4 million under its inaugural Advancing Science through Pfizer Investig...

Pfizer sNDA for Xalfori Accepted for Priority Review

[ Price : $8.95]

FDA accepts for priority review a Pfizer supplemental NDA for Xalkori (crizotinib) for treating patients with metastatic non-small...

FDA Guidance on Surgical Gowns

[ Price : $8.95]

FDA issues a guidance on Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings that descri...